The Anti-Inflammatory And Metabolic Effects Of Rosiglitazone In Subjects With Rheumatoid Arthritis

A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Anti-inflammatory and Metabolic Effects of Rosiglitazone XR, 8mg Once Daily, in Subjects With Rheumatoid Arthritis

To assess whether the anti-inflammatory effects of rosiglitazone result in improvements in Rheumatoid Arthritis symptoms in patients for whom their existing Disease Modifying Anti-Rheumatic Drug (DMARD) treatment does not give adequate relief.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: rosiglitazone XR

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania, LT-45130
    • GSK Investigational Site
  • Vilnius, Lithuania, LT-08661
    • GSK Investigational Site
• United Kingdom
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, G12 0YN
      • GSK Investigational Site
    • Glasgow, Lanarkshire, United Kingdom, G21 3UW
      • GSK Investigational Site
    • Glasgow, Lanarkshire, United Kingdom, G31 2ER
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Rheumatoid Arthritis insufficiently controlled by existing disease-modifying anti-rheumatic drugs
• Subjects will have at least 6 swollen joints plus 2 of the following: 6 tender joints (of 28 joints); early morning stiffness lasting more than 30 minutes; ESR greater or equal to 28mm/h
• must be receiving a stable dose of disease-modifying anti-rheumatic therapy for at least 2 months prior to participating in the study.

Exclusion criteria:

• Women who are lactating, pregnant, or planning to become pregnant during the course of the study including 30 days following conclusion of study medication
• Systolic blood pressure (SBP) >165 mmHg or diastolic blood pressure (DBP) >95 mmHg while receiving optimal antihypertensive therapy
• Any clinically significant abnormality identified on the screening physical exam, laboratory tests, or ECG, which in the judgement of the Investigator makes the subject unsuitable for inclusion in the study
• a history of alcohol abuse within the past 3 years or consumes >3 units per day for males and >2 units per day for females or has a history of cirrhosis or stigmata of chronic liver disease
• a history of liver disease or has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2.5 times upper limit of normal and total bilirubin levels greater than 1.5 times the upper limit of normal (unless associated with predominantly indirect bilirubin or Gilbert's syndrome) at screening
• using glucocorticoid at doses >10 mg/day currently or within the last 3 months or may be expected to do so during the course of the study
• The subject's dose of NSAIDs, COX-2 inhibitors or glucocorticoids has changed at any time during the past 2 weeks prior to screening or may be expected to change during the course of the study
• The subject's dose or treatment with a statin has changed at any time during the past 3 months prior to screening or may be expected to change during the course of the study
• a history of renal disease or has serum creatinine = 132mol/L for males and =130mol for females
• has diabetes mellitus that requires medication or hyperglycaemia with a HbA1c of >7%
• History of new cardiovascular event within the last 6 months (i.e., intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina) or significant arrhythmia; or major intervention (e.g., cardiac surgery or angiography plus stenting) scheduled
• Concurrent or past medical history of congestive heart failure or pulmonary oedema
• A presence of severe peripheral oedema or a medically serious fluid-related event
• has significant cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal or immunological conditions that, in the opinion of the Investigator and/or GSK medical monitor, places the subject at an unacceptable risk as a participant in this trial
• a history of malignancy in the last 5 years, except for surgically cured basal cell carcinoma (>2 years prior to first dosing)
• a history of HIV, or chronic hepatitis B or positive C serology
• a history of drug abuse
• has participated in a clinical trial within the 3 months before the start of the study for non-biological therapy; or within 6 months of a biological therapy
• on a biological therapy or has received biological therapy within 6 months prior to screening
• has donated blood in excess of 500 mL within 56 days prior to dosing
• The subject is at risk of non-compliance in following directions or adhering to study restrictions
• a history of drug or other allergy, which, in the opinion of the physician responsible, contraindicates their participation
• has anaemia defined by haemoglobin concentration <11 g/dL for males or <10 g/dL for females

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease Activity Score (DAS) following 6 months of treatment	6 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease activity at 3 months and 6 months, e.g., number of affected joints Patient Assessments of Improvements in Disease Activity, e.g., fatigue and pain assessment Assessment of safety, tolerability and biological activity	Disease activity at 3 months and 6 months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• This study has not been published in the scientific literature.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: September 21, 2006
• First Submitted That Met QC Criteria: September 21, 2006
• First Posted (Estimate): September 22, 2006

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; Anti-inflammatory treatment
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Hypoglycemic Agents; Physiological Effects of Drugs; Rosiglitazone
• Other Study ID Numbers: ARA102198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Statistical Analysis Plan
   Information identifier: ARA102198
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Individual Participant Data Set
   Information identifier: ARA102198
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Annotated Case Report Form
   Information identifier: ARA102198
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: ARA102198
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Clinical Study Report
   Information identifier: ARA102198
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: ARA102198
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Dataset Specification
   Information identifier: ARA102198
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register